Corcept Therapeutics Incorporated (CORT) announced that the pivotal phase III GRACE study, which evaluated its lead pipeline candidate, relacorilant, for treating patients with Cushing's syndrome, met its primary endpoint. Shares of the company were up 14.9% on May 28 following the announcement of the news. Treatment with relacorilant was well-tolerated in both phases of the GRACE study. The GRACE study consisted of two parts — the open-label portion and the randomized withdrawal phase. The study has now me ...

MENLO PARK, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced that GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing's syndrome), met its primary endpoint. The GRAC ...

Corcept Therapeutics Incorporated (CORT) reported first-quarter 2024 earnings of 25 cents per share, which beat the Zacks Consensus Estimate of 21 cents. The company had reported earnings of 14 cents per share in the year-ago quarter.Revenues increased 39% year over year to $146.8 million. The figure beat the Zacks Consensus Estimate of $138 million. The top line solely comprises product sales of Cushing’s syndrome drug, Korlym.Quarter in DetailRevenues from Korlym beat our model estimate of $129.8 million. ...

Financial Data and Key Metrics Changes - The company's revenue for Q1 2024 was $146.8 million, representing a 39% increase compared to the same quarter of the previous year [60] - Net income for the first quarter was $27.8 million, up from $15.9 million in the prior year [60] - Cash and investments as of March 31 were $451 million [60] - The revenue guidance for 2024 has been increased to a range of $620 million to $650 million [60] Business Line Data and Key Metrics Changes - The Korlym business continues to thrive, with a record number of new prescribers and patients [62] - The GRACE study showed that 63% of patients with hypertension met the study's response criteria, with significant improvements in blood pressure [68] - In the GRACE study, patients exhibited improvements in mean systolic and diastolic blood pressure of 12.6 and 8.3 mmHg from baseline, respectively [68] Market Data and Key Metrics Changes - The CATALYST study revealed that 25% of patients with difficult-to-control Type 2 diabetes were found to have hypercortisolism, indicating a higher prevalence than previously assumed [9] - The company is seeing increased awareness and diagnosis of Cushing's syndrome, which is expected to drive market growth [101] Company Strategy and Development Direction - The company is focused on advancing its proprietary selective cortisol modulator, relacorilant, which has shown promise in treating Cushing's syndrome and various cancers [63][70] - There is a strategic emphasis on enhancing disease awareness and screening for hypercortisolism, which is expected to expand the market for Korlym and relacorilant [25][89] - The company plans to explore broader applications of relacorilant in oncology, particularly in combination with chemotherapy agents [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of the Cushing's syndrome franchise due to the positive results from the GRACE study and increased disease awareness [15][25] - The company anticipates that the full impact of the CATALYST study will be felt in 2025 and beyond, as data generation takes time to translate into clinical practice [101] - Management is optimistic about the potential for relacorilant to improve patient outcomes in various conditions, including cancer [70] Other Important Information - The company is currently involved in ongoing litigation with Teva Pharmaceuticals regarding patent infringement related to Korlym, with a decision expected in early 2025 [61][67] - The GRACE study is a pivotal trial for relacorilant, with data expected to support the submission of a new drug application [63][68] Q&A Session Summary Question: What drove the revenue growth in Q1? - Management noted an increase in first-time prescribers, prescriptions, and patients on Korlym, driven by improved field execution [81][82] Question: How is the company addressing potential generic competition? - Management stated that they are prepared for generic competition and have a plan in place to defend market share while continuing to grow the business [41][95] Question: What is the expected impact of the CATALYST study? - Management believes that the CATALYST results will increase screening for hypercortisolism, but the full impact will take time to materialize [101] Question: What is the confidence level regarding the randomized withdrawal phase of the GRACE study? - Management expressed strong belief that 12 weeks is sufficient to observe a statistically significant difference in patient outcomes [103] Question: How will the company approach commercialization if relacorilant is approved? - Management indicated plans to switch patients from Korlym to relacorilant while leveraging the existing market for both products [105]

[Part I. Financial Information](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) The company's Q1 2024 financial statements reflect significant growth in revenue, net income, and total assets [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets grew to $655.9 million as of March 31, 2024, with a decrease in total liabilities Balance Sheet Summary (in thousands) | Balance Sheet Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $149,750 | $135,551 | | Total current assets | $503,367 | $458,636 | | **Total assets** | **$655,935** | **$621,517** | | Total current liabilities | $97,202 | $104,505 | | **Total liabilities** | **$108,071** | **$114,812** | | **Total stockholders' equity** | **$547,864** | **$506,705** | [Condensed Consolidated Statements of Income](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME) Net product revenue grew 39% year-over-year to $146.8 million, driving net income to $27.8 million Q1 2024 vs Q1 2023 Income Statement (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Product revenue, net | $146,808 | $105,654 | | Research and development | $58,505 | $40,851 | | Selling, general and administrative | $56,268 | $48,564 | | Income from operations | $29,500 | $14,853 | | **Net income** | **$27,762** | **$15,879** | | **Diluted net income per common share** | **$0.25** | **$0.14** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash from operations was $23.8 million, and cash and cash equivalents increased by $14.2 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $23,756 | $25,957 | | Net cash (used in) provided by investing activities | $(9,014) | $207,475 | | Net cash (used in) provided by financing activities | $(543) | $181 | | **Net increase in cash and cash equivalents** | **$14,199** | **$233,613** | [Notes to Condensed Financial Statements](index=9&type=section&id=NOTES%20TO%20CONDENSED%20FINANCIAL%20STATEMENTS) Notes detail key events including a $14.0 million litigation settlement and a new $200 million stock repurchase program - The company is a commercial-stage pharmaceutical firm focused on medications that modulate cortisol, with its primary product being **Korlym®** for Cushing's syndrome[22](index=22&type=chunk) - The Melucci securities class action lawsuit was **settled for a one-time payment of $14.0 million**, which was fully covered by the company's insurers[40](index=40&type=chunk) - In January 2024, the Board of Directors authorized a **new stock repurchase program for up to $200 million** of common stock, with $199.5 million available as of March 31, 2024[47](index=47&type=chunk)[48](index=48&type=chunk) - Subsequent to quarter-end, the company **extended its pharmaceutical manufacturer services agreement** with Optime Care, Inc, to March 31, 2027[65](index=65&type=chunk) - On April 12, 2024, the company entered into a **six-year sublease for a new headquarters** in Redwood City, CA, with lease obligations of approximately $9.6 million[67](index=67&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses strong Q1 2024 performance driven by Korlym sales and progress in the clinical pipeline [Overview](index=16&type=section&id=Overview) The company markets Korlym® for Cushing's syndrome and advances its pipeline, including positive relacorilant trial data - The company's lead product, **Korlym**, is marketed for the treatment of Cushing's syndrome[71](index=71&type=chunk)[72](index=72&type=chunk) - In April 2024, preliminary results from the GRACE Phase 3 trial of relacorilant showed **clinically meaningful and statistically significant improvements** in hypertension and hyperglycemia[77](index=77&type=chunk) - **Enrollment is complete** for the ROSELLA Phase 3 trial in ovarian cancer and the DAZALS Phase 2 trial in ALS[88](index=88&type=chunk)[91](index=91&type=chunk) - The **MONARCH Phase 2b trial** of miricorilant in patients with NASH was initiated in October 2023[92](index=92&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q1 2024 net product revenue rose 39% to $146.8 million, while operating expenses increased due to clinical program costs Q1 2024 vs Q1 2023 Operating Results (in millions) | Line Item | Q1 2024 | Q1 2023 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue | $146.8 | $105.7 | +38.9% | Higher sales volume (67.6%) and price increase (32.4%) | | Cost of Sales | $2.5 | $1.4 | +78.6% | $0.5M write-off of API | | R&D Expense | $58.5 | $40.9 | +43.0% | Increased spending on development programs | | SG&A Expense | $56.3 | $48.6 | +15.8% | Increased employee compensation and marketing activities | [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity with $451.0 million in cash and investments, sufficient for future operations - As of March 31, 2024, the company held **$451.0 million in cash, cash equivalents, and marketable securities**[111](index=111&type=chunk) - The company **relies on revenues from the sale of Korlym** to fund its operations and expects to do so for the next 12 months and beyond[109](index=109&type=chunk)[110](index=110&type=chunk) - **Net cash provided by operating activities was $23.8 million** for the three months ended March 31, 2024[113](index=113&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Market risks associated with cash and investments have not materially changed from the prior annual report - Market risks associated with cash, cash equivalents, and marketable securities **did not change materially** during the three months ended March 31, 2024[119](index=119&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective with no material changes in internal controls - The CEO and CFO concluded that as of March 31, 2024, the company's **disclosure controls and procedures were effective**[120](index=120&type=chunk) - **No changes** during the quarter materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[121](index=121&type=chunk) [Part II. Other Information](index=22&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=22&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company faces significant legal matters including patent litigation, a settled class action, and a government inquiry - Teva Litigation: A court ruled **Teva's proposed generic Korlym would not infringe** Corcept's patents; Corcept has appealed, and Teva has launched its generic product[124](index=124&type=chunk) - Hikma Litigation: The company **settled with Hikma**, granting it the right to sell a generic version of Korlym beginning October 1, 2034, or earlier under certain circumstances[127](index=127&type=chunk) - Melucci Litigation: A securities class action was **settled for $14.0 million**, to be paid in full by insurers, pending final court approval[129](index=129&type=chunk) - The company received a **subpoena from the U.S. Attorney's Office** for the District of New Jersey regarding the sale and promotion of Korlym and is cooperating[134](index=134&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=ITEM%201A.%20RISK%20FACTORS) Key risks include reliance on Korlym, generic competition, regulatory pricing pressures, and clinical development uncertainty - Commercial risk: The company's financial results depend heavily on Korlym, which is now **threatened by the launch of a generic version by Teva**[138](index=138&type=chunk)[150](index=150&type=chunk) - Regulatory risk: The **Inflation Reduction Act of 2022 (IRA) could significantly limit revenue** from Medicare patients through price negotiation and inflation rebates[139](index=139&type=chunk)[157](index=157&type=chunk)[159](index=159&type=chunk) - Development risk: Efforts to develop new product candidates are lengthy, expensive, and **may not succeed**, with failure possible at any stage[148](index=148&type=chunk)[179](index=179&type=chunk) - Intellectual Property risk: The company **must secure and defend its patent protection** for its products, which involves complex, costly, and uncertain litigation[142](index=142&type=chunk)[192](index=192&type=chunk) - Operational risk: The company **relies on a single specialty pharmacy (Optime)** to dispense Korlym and on other vendors for manufacturing[162](index=162&type=chunk)[163](index=163&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company repurchased $0.5 million of its common stock under a new $200 million repurchase program Issuer Purchases of Equity Securities (Q1 2024) | Program | Total Shares Repurchased | Average Price Paid Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | Stock Repurchase Program | 20,000 | $23.82 | $524 | | Cashless Exercises/Vesting | 143,000 | $24.75 | $3,555 | - On January 8, 2024, the Board of Directors authorized a **new stock repurchase program for up to $200 million** of common stock, with **$199.5 million remaining available** as of March 31, 2024[224](index=224&type=chunk) [Item 5. Other Information](index=41&type=section&id=ITEM%205.%20OTHER%20INFORMATION) The company's Chief Business Officer adopted a Rule 10b5-1 trading plan for the potential sale of company stock - Charles Robb, Chief Business Officer, **adopted a Rule 10b5-1 trading plan** on February 22, 2024, to sell up to 44,000 shares of common stock[231](index=231&type=chunk) [Item 6. Exhibits](index=42&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with the Form 10-Q, including agreements and required officer certifications

EXHIBIT 99.1 CORCEPT THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE The company increased its 2024 revenue guidance to $620 – $650 million. Clinical Development "The results of the open-label phase of our GRACE trial, which we released last week, are compelling," said Dr. Belanoff. "We expect to build on these results in the trial's randomized withdrawal phase. Results from this portion of the study will be available in the coming weeks. We are on track to submit our ND ...

Corcept Therapeutics Incorporated (CORT) announced positive data from one part of the pivotal phase III GRACE study, which evaluated its lead pipeline candidate, relacorilant, for treating patients with all etiologies of endogenous Cushing’s syndrome.The GRACE study consists of two parts. The above mentioned data was from the open-label portion of the study in which patients with Cushing’s syndrome and either hypertension, hyperglycemia or both were treated with relacorilant for a period of 22 weeks.Data fr ...

MENLO PARK, Calif., April 22, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced positive results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective cortisol modulator relacorilant in patients with all etiologies of end ...

Corcept Therapeutics (CORT) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the sy ...

Corcept Therapeutics Incorporated (CORT) announced that it has completed enrollment in the phase II DAZALS study, which is evaluating its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis (ALS), a degenerative neurologic disorder.The primary endpoint of this double-blind, placebo-controlled phase II study is to see the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R), a measure of motor impairment and functional deterioration in AL ...